EFRACEA

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOXYCYCLINE

Available from:

Galderma (UK) Ltd

ATC code:

J01AA02

INN (International Name):

DOXYCYCLINE

Dosage:

40 Milligram

Pharmaceutical form:

Capsules Modified Release

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

doxycycline

Authorization status:

Marketed

Authorization date:

2009-01-30

Patient Information leaflet

180MM
315MM
315MM
180MM
315MM
315MM
180MM
315MM
315MM
180MM
315MM
315MM
180MM
315MM
315MM
Laboratoires GALDERMA, Zone Industrielle Montdésir, 74540 Alby sur
Chéran, France
Laboratoires GALDERMA, Zone Industrielle Montdésir, 74540 Alby sur
Chéran, France
Laboratoires GALDERMA, Zone Industrielle Montdésir, 74540 Alby sur
Chéran, France
Laboratoires GALDERMA, Zone Industrielle Montdésir, 74540 Alby sur
Chéran, France
Laboratoires GALDERMA, Zone Industrielle Montdésir, 74540 Alby sur
Chéran, France
Laboratoires GALDERMA, Zone Industrielle Montdésir, 74540 Alby sur
Chéran, France

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
EFRACEA 40 mg modified-release hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg doxycycline (as monohydrate).
Excipients with known effect: 102 – 150 mg of sucrose and 26.6 -
29.4 µg of Allura red AC
aluminium lake (E129).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release hard capsule
Beige capsule, No. 2 size, bear the marking “GLD 40”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Efracea is indicated to reduce papulopustular lesions in adult
patients with facial rosacea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, including older people:_
Oral use.
The daily dose is 40 mg (1 capsule).
_Patients with renal impairment_
No dosage adjustment is necessary in patients with renal impairment.
_Patients with hepatic impairment_
Efracea should be administered with caution to patients with hepatic
impairment
or
to those receiving potentially
hepatotoxic medicinal products (see section 4.4)
_Paediatric population_
Efracea is contraindicated in children below 12 years of age (see
section 4.3).
Method of administration
THE CAPSULE SHOULD BE TAKEN IN THE MORNING, ON AN EMPTY STOMACH,
PREFERABLY AT LEAST ONE HOUR PRIOR TO OR TWO
HOURS AFTER THE MEAL.
THE CAPSULE SHOULD BE TAKEN WITH ADEQUATE AMOUNTS OF WATER IN ORDER TO
REDUCE THE RISK OF OESOPHAGEAL
IRRITATION AND ULCERATION (SEE SECTION 4.4).
Patients should be evaluated after
6 weeks and,
if
no effect
is
seen,
consideration should be given to stopping
treatment.
In clinical
trials patients were treated for 16 weeks.
Upon discontinuation,
lesions tended to reappear at
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